Incontinence collection device and related methods

ABSTRACT

An external incontinence collection device that includes a novel one-way valve system for preventing backflow from a collection receptacle. The incontinence collection device also includes novel drainage valve structures that improve the drainage functionality.

FIELD OF THE INVENTION

The present invention relates to external incontinence collectiondevices and methods for using the same. More specifically, theembodiments of the present invention pertain to external incontinencecollection devices that may include one-way valve structures forcontrolling backflow and/or novel drainage valves.

DISCUSSION OF THE BACKGROUND

Male urinary incontinence is a common medical problem. Commonly usedmale urinary incontinence devices include absorbent diapers, invasiveurinary catheters and/or external, non-invasive urine collectiondevices. Each device either subjects the user to adverse health issues.For example, diapers are associated with a high rate of skin breakdownand ulcer formation while indwelling urinary catheters are a cause ofurinary tract infections (UTI). Accordingly, there is a great demand fornon-invasive external incontinence devices for collecting urine frommales without that does not cause skin break down or UTI.

Urine collection devices are typically attached to or inserted into auser's body for the purpose of collecting urine or allowing the user tovoid the bladder. The present devices in the field include, but are notlimited to, urinary catheters, Foley catheters, suprapubic catheters,nephrostomy catheters, condom catheters, and external incontinencedevices. Of these devices, conventional incontinence devices may collecturine excreted from into a urine collection bag or may enable the userto immediately void the user's bladder. More recently a line of productshave come out to address the need for a urinary incontinence device formales that attaches externally, however, there are issues with thecurrent devices.

Current external urine collection devices have incorporated a parameatalseal to be adhesively secured to the end of the glans penis to preventleakage of urine. One prominent issue with the current seal is thatusers incorrectly attach the device resulting in the urine leakage. Theaddition of multiple attachment members, such as a plurality of petalsin addition to a strap, has been used to try and address the problem.However, additional attachment member(s) has not solved the problem. Forusers, multiple attachment members may increase the likelihood ofcreating a poor seal resulting in urine leakage, requiring thereattachment or replacement of the attachment members.

Even with the attachment members optimally positioned and attached, theattachment members may fail due to backflow of urine to the attachmentmembers, which can cause detachment of the incontinence collectiondevice. The adhesive attaching the device to the user is dissolved whensubjected to a warm liquid. In current devices, the collection conduitthat collects excreted urine does not adequately prevent backflow.Conventional devices allow urine to flow back into the collectionconduit and come in contact with the dissolvable adhesive. Due to thefact that urine is warm, upon backflow of urine, the adhesive maydissolve leading to the detachment of the device from the user and urinespillage. For example, one may dissolve the adhesive by simply tiltingthe device towards the collection conduit (e.g., by leaning back,reclining in a chair, crossing a leg, etc.). Thus, common acts may leadto the backflow of urine and failure of the adhesive, resulting indetachment of the incontinence device.

Yet another issue with the current external male incontinence device isthe drainage valve. Often times the drainage valve is a snap-fit valve(similar to the basic air retention valves found in inflatablemattresses, flotation devices, and pool toys). The user has to disengagethe exit valve manually by removing the cap of the snap-fit valve torelease the urine collected in the urine receptacle. It is difficult fora user to control the flow of urine when initially opening the snap-fitvalve cap because the valves are clumsy and awkward and require twohands to operate. Therefore, the user may spill urine onto their handsor other undesirable places when trying to empty the urine receptaclewhen opening the snap-fit exit valve.

Therefore, it is desirable to have an improved incontinence collectiondevice and methods for using the same.

SUMMARY OF THE INVENTION

The present invention is directed to embodiments of incontinencecollection devices that may include valve structures for preventingbackflow of urine and/or a valve structure that allows for a controlledand cleanly drainage of urine from the device. The features of thepresent embodiments provide for improved urine collection and storageover conventional devices, allowing the user to avoid detachment of thedevice, urine spillage, and clumsy drainage of the device. Theembodiments of the present invention also include methods of operationand use of the incontinence collection devices of the present invention.Discussion of the features of the incontinence collection devices of thepresent invention are provided below.

The incontinence collection devices of the present invention may includean innovative attachment structure that improves sealing between theincontinence device and the penis, making the attachment easier andhelping to prevent or reduce the risk of detachment of the incontinencedevice. In some embodiments, the attachment structure may include aconcave, flexible receiver for placement on the end of the user's peniswhere urine is excreted (e.g., the glans penis). The concave receivermay be shaped to approximate the shape of the glans penis or a portionthereof. The concave receiver may be made from a polymer material suchas a silicone rubber, polyurethane rubber, non-vulcanized naturalrubber, polystyrene rubbers, polychloroprene, non-latex rubber materials(e.g., nitrile), and other sturdy, flexible materials that can safelycontact the skin. The flexibility of the concave receiver may allow foraccommodation of variations in anatomy. The concave receiver may alsoinclude a collection hole (e.g., an elliptical hole) to allow urine topass from the concave receiver to a collection conduit in fluidcommunication with the concave receiver. The collection hole may besurrounded by a raised bead (a rim or lip, e.g., having an elliptical oroblong perimeter) that may be positioned to abut the glans penis andsurround the external urethral orifice (urethral meatus), such that asurine is excreted it is captured within the raised bead and is preventedfrom flowing to peripheral portions of the concave receiver that areexterior to the raised bead. The interior surface of the concavereceiver may be coated with an adhesive to allow the concave receiver tobe adhered to the glans penis and seal concave receiver to the glanspenis such that urine is directed into the collection hole of theconcave receiver. In the process of adhering the concave receiver to theglans penis, the raised bead and the collection hole may be aligned withthe exterior urethral orifice, such that urine is directly andefficiently drained through the collection hole. The collection hole maybe in fluid communication with a collection conduit that receives urinepassing through the collection hole.

In some embodiments, the attachment member may also have a one or moreadhesive flaps or tabs that may aid in attaching the incontinencecollection device to the penis. These adhesive flaps or tabs may includean adhesive on side thereof to allow them to be adhered to the skin ofthe penis (e.g., on the glans penis and/or the body of the penis). Insome embodiments, the adhesive flaps may be attached to the outer sideof the concave receiver, providing adhesion attachment strength for theincontinence collection device. In some implementations, the adhesiveflaps may radiate out from the concave receiver like petals, allowingthe flaps to provide further adhesion around the circumference of thepenis. In other embodiments, the device may include an adhesive bandagestructure having a central adhesive pad with adhesive flaps radiatingout from the central adhesive pad, with no concave receiver included. Insuch embodiments, a collection disk may be provided in the centraladhesive pad. The collection disk may include a collection hole thereinfor receiving urine from the external urethral orifice.

In some embodiments, the attachment member may also have an adhesivestrap that may aid in attaching the incontinence collection device tothe penis. The adhesive strap may include an adhesive on one sidethereof to allow the strap to be adhered to the skin of the penis (e.g.,on the glans penis and/or the body of the penis). The adhesive strap maybe made of a flexible material so that the adhesive strap may wraparound the penis thereby helping secure the incontinence device to thepenis. In some embodiments, the adhesive strap may be attached to theconcave receiver, providing adhesion attachment strength for theincontinence collection device. In some implementations, the adhesivestrap may be included in the incontinence collection device incombination with the one or more adhesive flaps or tabs, providingfurther adhesion attachment strength for the incontinence device. In yetanother embodiment, the adhesive strap may be included in theincontinence collection device in combination with the concave receiverand or the one or more adhesive flaps or tabs thereby providing furtheradhesion attachment strength for the incontinence device.

In some embodiments, the incontinence collection devices of the presentinvention include a collection valve that is in fluid communication withthe collection conduit and receives urine therefrom. The collectionvalve may be a one way valve that prevents backflow into the collectionconduit and the collection hole. The collection valve may be of variousone-way internal valve designs. In some embodiments, the collectionvalve may have a double membrane structure, in which the distal ends ofthe membrane are intermittently bonded together, such that there areintermittent passages between the membranes at or near the distal endsthereof that allow urine to pass downstream from the collection holethrough the collection valve, but the distal ends of the membrane areprevented from separating and allowing backflow. The passages betweendistal ends of the dual membranes have a width in the range of about 1mm to about 5 mm (e.g., about 1.5 mm to about 4 mm, about 2 mm to about3.5 mm, or any value or range of values therein) and the bonding pointsbetween the membranes may have widths in the range of about 1 mm toabout 3 mm (e.g., about 2 mm, or any value or range of values therein).The width of the bonding points may define the interval between adjacentpassages. The collection valve allows urine to pass at low pressure andflow into a second collection conduit at the distal end of thecollection valve. The urine may seep through the plurality of passagesinto the second collection conduit.

In some embodiments, the incontinence collection device may not includea concave receiver. In such embodiments, the collection valve mayinclude a collection conduit at its proximal end for receiving urinedirectly from the external urethral orifice, which may engage with acentral adhesive pad, as described above. The central adhesive pad mayhave a collection hole (e.g., an elliptical hole) therein for receivingand engaging the collection conduit of the collection valve, which maybe placed in direct contact with the glans penis in order to collectexcreted urine. The collection conduit may be secured to the centraladhesive pad by an adhesive or other fastening mechanism.

Once the urine passes through the collection valve and into the secondcollection conduit, the urine may pass into a collection receptaclewhich has a proximal receiving hole in fluid communication with thesecond collection conduit. The collection receptacle may have a volumesufficient to hold several hours of average urine excretion for an adultmale. For example, the collection receptacle may have a maximum volumein a range of about 8 fluid oz. to about a quart. The collectionreceptacle may be made of a flexible material (e.g., rubber,polyurethane rubber, non-latex material such as nitrile, etc.) to allowthe structure to collapse when empty or nearly empty, and to conform tothe body as a person wearing the incontinence collection device moves.

The collection receptacle may include a one-way valve of variousdesigns. In some embodiments, the one-way valve of the collectionreceptacle may have a similar structure to the one-way valve of thecollection valve. In such embodiments, the collection valve may have adouble membrane structure, in which the distal ends of the membrane areintermittently bonded together, such that there are intermittentpassages between the membranes at or near the distal ends thereof thatallow urine to pass downstream from the collection valve into thecollection receptacle, but the distal ends of the membrane are preventedfrom separating and allowing backflow. The passages between distal endsof the dual membranes have a width in the range of about 1 mm to about20 mm (e.g., about 5 mm to about 15 mm, about 8 mm to about 12 mm, orany value or range of values therein) and the bonding points between themembranes may have widths in the range of about 1 mm to about 20 mm(e.g., about 3 mm to about 18 mm, about 5 mm to about 15 mm, or anyvalue or range of values therein). The width of the bonding points maydefine the interval between adjacent passages. The one-way valve of thecollection receptacle allows urine to pass at low pressure (e.g., seepthrough the plurality of passages) and flow into the collectionreceptacle for storage. In some implementations, the dual membraneone-way valve may be connected along a lateral edge to the interior ofthe collection receptacle in order to aid in keeping the dual membranestructure in a flattened arrangement with the two membranes interfacingwith one another in close proximity. The connection of the dualmembranes to the interior of the collection receptacle may aid inpreventing backflow of urine through the one-way valve to the collectionvalve.

In some implementations, the collection receptacle may have a structuralfeatures that allow the receptacle to expand with the flow of urine intothe collection receptacle at relatively low pressures. For example, thecollection receptacle may include billow-like structures or pleats atone or more points along the wall of the collection receptacle. Suchbillow-like structures or pleats may facilitate the collapse of thereceptacle into a flat arrangement, such that the walls of receptacleare roughly parallel to the dual membrane one-way valve therein. Thedual membranes of the one-way valve structure may be attached to thecollection receptacle at or near the billow-like structure or pleats tofurther facilitate the collapsed, flat arrangement.

The collection receptacle may include a drainage conduit at itsinferior, distal end for draining fluid from the collection receptacle.The drainage conduit may incorporate a drainage valve at the distal end.In some embodiments, the valve be of various designs that allow the userto open the drainage conduit without needing to have his hands near thedistal opening of the drainage conduit. Thus, the drainage conduit mayhave a sufficient length to allow the drainage valve to be positionedsufficient distance upstream of the distal end of the drainage conduit,such that the collection receptacle can be drained without the usergetting urine on his hands or spillage of the urine on the user or otherundesirable places (e.g., the floor, user's pants, etc.). The drainageconduit may have a length in a range of about ¼ inch to about fiveinches (e.g., about a ¼ inch to about two inches, or any value or rangeof values therein).

The valve may be of various designs that are operable to be positionedin-line in the drainage conduit and upstream of the distal opening ofthe drainage conduit (e.g., butterfly valve, cross valve, pinch valve,etc.). The user may manually control the drainage valve in order todrain the urine from the collection receptacle into a desired location(e.g., a toilet). In some embodiments, the drainage valve is a pinchvalve having a compressible bulb with a flexible actuator having a plugfor mechanically blocking the distal end of the compressible bulb. Thepinch valve may have closed condition (no pressure applied to the pinchvalve by the user), in which the plug obstructs the distal end of thevalve to prevent flow through the valve, and an open condition (userapplies pressure to the pinch valve) in which the plug is proximallyretracted from the end of the valve to allow flow through the valve. Insome embodiments, the flexible actuator includes two or more (e.g.,three, four, six, eight, etc.) resilient arms each having an outwardlyprotruding elbow that rests near or engages with the interior side ofthe wall of the compressible bulb. In some embodiments, the elbows maybe mechanically attached to the interior of the compressible bulb tokeep the resilient flexible frame in place within the compressible bulb.In other embodiments, the elbows may not be mechanically attached to theinterior of the bulb. The flexible actuator may also include one or morecentral members connected to the resilient arms at or near a proximalend of the one or more central members and to the plug at the distal endof the one or more central members. The one or more central members mayact as a piston that moves (1) proximally when the valve is pinched bythe user, thereby retracting the plug away from the distal end of thevalve, and (2) distally when the valve is released by the user, therebyinserting the plug into the distal end of the valve to obstruct passageof fluid through the valve. In operation, when the user engages thepinch valve (e.g., by compressing the bulb), the two or more resilientarms extend longitudinally, thereby moving the one or more centralmembers proximally and retracting the plug and allowing urine to flowfrom the collection receptacle through the pinch valve. Upon release ofthe pinch valve, the two or more resilient arms resile to their originallengths and the central member(s) and the plug move distally and theplug seals the valve. It is to be understood that other valve structuresoperable to positioned in-line in the drainage conduit are encompassedwithin the scope of the present invention.

In some implementations, the drainage valve may detachable so that itmay be replaced. In such implementations, the drainage valve may includea coupling mechanism that allows the valve to be attached and secured tothe end of the drainage conduit, such as threading, interlocking ridgeswith the distal end of the drainage conduit, etc.

The incontinence collection devices of the present invention may alsoinclude a relief valve to allow gas (e.g., air) to pass into theincontinence collection device as urine flows out of the device. Therelief valve may facilitate unimpeded flow of urine through thestructures of the incontinence collection device (e.g., the collectionreceptacle, the drainage conduit, etc.) at low fluid pressure. The airrelief valve may be positioned at various points on the incontinencecollection devices of the present invention, including, but not limitedto, the collection valve, the collection receptacle, etc.

Male external incontinence devices are typically attached to the glanspenis. It is to be appreciated that such conditions as urostomy whereinan ureteroenteric anastomosis or ileal conduit urinary diversion iscreated so that one excretes urine in a different place than the glanspenis. A urostomy is a surgical procedure that creates an artificialopening (typically called the stoma) for the urinary system. A urostomyprocedure is performed on an individual where voiding of the bladderthrough the urethra is not possible (e.g., after extensive surgery, anobstruction, etc.), and urine excretion is rerouted through a stoma inthe abdominal wall. The incontinence collection devices of the presentinvention may be used with a surgically created excretion points, suchas a stoma, wherein urine is excreted. In such cases, embodiments of theincontinence collection device that include an adhesive pad forcontacting the excretion point (e.g., rather than a concave receiver)may be used for attaching the incontinence collection device to theabdominal wall and engaging the receiving conduit with the stoma.

In one aspect, the present invention relates to an incontinencecollection device that includes an attachment member having an adhesiveon a surface of the attachment member and an exit hole for allowing thepassage of urine, wherein the attachment member is operable to attach toa distal end of a penis; a collection member connected to the attachmentmember, the collection member comprising a collection conduit having aproximal end in fluid communication with the attachment member, aone-way internal valve in fluid communication with the collectionconduit that is operable to prevent backflow of urine, and a distalconduit; a collection receptacle in fluid communication with the distalconduit of the collection member; and an air relief valve in fluidcommunication with the collection receptacle. The one-way valve includesa flexible dual membrane structure. The collection member may include aconcave receiver operable to engage with the end of the penis, and maybe conformable to the end of the penis and the concave receiver may havean adhesive on an interior thereof for adhering the concave receiver tothe penis. The collection receptacle may include a second one-way valvefor preventing backflow from the collection receptacle. The collectionreceptacle may have an exit conduit at a distal end thereof and adrainage valve. The drainage valve may be a pinch valve comprising acompressible bulb having a drainage hole in a distal end thereof; and aresilient, flexible valve mechanism comprising an actuator having atleast two resilient arms having an elbow therein, the arms being inmechanical connection with an interior of the compressible bulb; acentral member including a piston member having a proximal end that ismechanically connected to proximal ends of the resilient arms, and adistal end, a plug attached to the distal end of the bar, wherein theplug is operable to seal the drainage hole.

In another aspect, the present invention relates to an incontinencecollection device that includes a collection member connected to anattachment member, the collection member comprising a collection conduithaving a proximal end in fluid communication with a collection hole, afirst one-way valve in fluid communication with the collection hole thatis operable to prevent backflow of urine, and a distal conduit; acollection receptacle in fluid communication with the distal conduit ofthe collection member, the collection receptacle includes a secondone-way valve for preventing backflow from the collection receptacle;and a drainage conduit in fluid communication with the collectionreceptacle operable to drain fluid from the collection receptacle. Thecollection member may include a concave receiver operable to engage withthe end of the penis having a collection hole for alignment with theexternal urethral orifice of the penis and a raised bead surrounding thecollection hole on the interior thereof, and the concave receiver isconformable to the end of the penis and the concave receiver has anadhesive on an interior thereof for adhering the concave receiver to thepenis. The first one-way valve may include a flexible dual membranesthat are connected together at their edges and have intermittentpassages between the dual membranes at distal ends thereof. Theincontinence collection device may include a drainage valve in fluidcommunication with the drainage conduit. The drainage valve may be apinch valve comprising a compressible bulb having a drainage hole in adistal end thereof; and a resilient, flexible valve mechanism comprisingan actuator having at least two resilient arms having an elbow therein,the arms being in mechanical connection with an interior of thecompressible bulb; a central member including a piston member having aproximal end that is mechanically connected to proximal ends of theresilient arms, and a distal end, a plug attached to the distal end ofthe bar, wherein the plug is operable to seal the drainage hole.

In another aspect, the present invention relates to an incontinencecollection device that includes a collection member connected to anattachment member, the collection member comprising a concave receiveroperable to engage with an end of a penis having a collection hole foralignment with the external urethral orifice of the penis; a collectionconduit having a proximal end in fluid communication with the collectionhole, a one-way valve in fluid communication with the collection holethat is operable to prevent backflow of urine, and a distal conduit; acollection receptacle in fluid communication with the distal conduit ofthe collection member; and a drainage conduit in fluid communicationwith the collection receptacle operable to drain fluid from thecollection receptacle. The incontinence collection device may include adrainage valve in fluid communication with the drainage conduit. Theconcave receiver may be conformable to the end of the penis and theconcave receiver has an adhesive on an interior thereof for adhering theconcave receiver to the penis. The one-way valve may include flexibledual membranes that are connected together at their edges and haveintermittent passages between the flexible dual membranes at distal endsthereof. The collection receptacle may include a second one-way valvefor preventing backflow from the collection receptacle. The drainagevalve may be a pinch valve comprising a compressible bulb having andrainage hole in a distal end thereof; and a resilient, flexible valvemechanism comprising an actuator having at least two resilient armshaving an elbow therein, the arms being in mechanical connection with aninterior of the compressible bulb; a central member including a pistonmember having a proximal end that is mechanically connected to proximalends of the at least two resilient arms, and a distal end, and a plugattached to the distal end of the bar, wherein the plug is operable toseal the drainage hole.

It is to be understood that both the general description and thefollowing detailed description are exemplary and explanatory only andare not meant to limit the present invention. One with ordinary skill inthe art will recognize that the general description and the detaileddescription will recognize that alterations and equivalents notdescribed herein are captured in the spirit of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of a urine collector according to someembodiments of the present invention

FIG. 1B shows a perspective view of a urine collector according to someembodiments of the present invention.

FIG. 1C shows a top view of a urine collector according to someembodiments of the present invention.

FIG. 1D shows a side view of a urine collector according to someembodiments of the present invention

FIG. 2A shows an front view of the attachment device according to someembodiments of the present invention.

FIG. 2B shows a perspective view of a urine collector according to someembodiments of the present invention.

FIG. 2C shows a top view of a urine collector according to someembodiments of the present invention.

FIG. 2D shows a side view of a urine collector according to someembodiments of the present invention.

FIG. 3A shows a top view of an attachment device according to someembodiments of the present invention.

FIG. 3B shows an perspective view of an attachment device according tosome embodiments of the present invention.

FIG. 3C shows a top view of an attachment device according to someembodiments of the present invention.

FIG. 4A shows a frontal view of a collection receptacle with a drainagevalve according to some embodiments of the present invention.

FIG. 4B shows a frontal view of a collection receptacle with a drainagevalve according to some embodiments of the present invention.

FIG. 4C shows a frontal view of a collection receptacle with a drainagevalve according to some embodiments of the present invention.

FIG. 4D shows a frontal view of a collection receptacle with a drainagevalve according to some embodiments of the present invention.

FIG. 4E shows a frontal view of a collection receptacle with a drainagevalve according to some embodiments of the present invention.

FIG. 5A shows a perspective view of an incontinence control deviceaccording to some embodiments of the present invention

FIG. 5B shows a perspective view of an incontinence control deviceaccording to some embodiments of the present invention.

FIG. 5C shows a perspective view of an incontinence control deviceaccording to some embodiments of the present invention.

FIG. 5D shows a perspective view of an incontinence control deviceaccording to some embodiments of the present invention.

FIG. 6A shows a perspective view of a step in the process of attachingan incontinence control device according to some embodiments of thepresent invention.

FIG. 6B shows a perspective view of a step in the process of attachingan incontinence control device according to some embodiments of thepresent invention.

FIG. 6C shows a perspective view of a step in the process of attachingan incontinence control device according to some embodiments of thepresent invention.

FIG. 7A shows a perspective view of an undergarment according to someembodiments of the present invention.

FIG. 7B a frontal view of a collection receptacle with a drainage valveaccording to some embodiments of the present invention.

FIG. 7C shows a perspective view of an undergarment according to someembodiments of the present invention.

FIG. 7D shows a perspective view of an undergarment according to someembodiments of the present invention.

FIG. 7E shows a perspective view of an undergarment according to someembodiments of the present invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Reference will now be made in detail to certain embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in reference to theseembodiments, it will be understood that they are not intended to limitthe invention. To the contrary, the invention is intended to coveralternatives, modifications, and equivalents that are included withinthe spirit and scope of the invention as defined by the claims. In thefollowing disclosure, specific details are given to provide a thoroughunderstanding of the invention. However, it will be apparent to oneskilled in the art that the present invention may be practiced withoutthese specific details.

FIGS. 1A-D collectively show, without limitation, a collection member100. Referring to FIG. 1A-B, the collection member 100 is made up of aconcave receiver 136 (e.g., a cup), a collection valve 105 having aproximal end in fluid connection with concave receiver 136, and distalcollection conduit 120. The concave receiver 136 is a cup-like structurethat is operable to be placed at the distal end of the penis (glanspenis), and form-fit to the glans-penis to provide a relatively largesurface area interaction between the concave receiver and the glanspenis. The interior surface of the concave receiver 136 may have anadhesive thereon for adhering the concave receiver 136 to the glanspenis. The adhesive may be a skin-safe adhesive such as hydrocolloid,acrylic, silicone, latex, or non-latex adhesive formulation. Thecup-like structure may also aid in collecting excreted urine byproviding a relatively large vessel for catching the excreted urine. Theconcave receiver 136 may include a collection hole 103 and a raised bead103 a that surrounds the collection hole 103. FIG. 1C shows the proximalsurface of the concave receiver 136 that includes the raised bead 103 a.The collection hole 103 may be aligned with external urethral orificewith the raised bead 103 a surrounding the external urethral orifice toprevent leakage and direct urine flow through the collection member 105.The raised bead 103 a may have adhesive for attaching and sealing theconcave receiver to the glans penis to thereby securely align thecollection hole 103 with the external urethral orifice.

The collection valve 105 includes a flexible, water-tight outer membranewall 105 a (e.g., a sleeve-like polymer structure) operable to allowurine to pass therethrough without leakage. The outer membrane wall 105a may have a water-tight connection at its proximal end with the concavereceiver 136 and at its distal end with distal collection conduit 120.The collection valve 105 includes a one-way internal valve 110 that maybe nested within the outer membrane wall 105 a. The one-way internalvalve 110 may have a flexible dual membrane structure 115 in which thelateral edges of the dual membranes are bonded to each other and thedistal ends of the membranes are intermittently bonded together atbonding points 102 a, such that there are intermittent passages 102 bbetween the membranes at or near the distal ends thereof. This dualmembrane structure 115 allows urine to pass downstream from thecollection hole 103 through the one-way internal valve 110 without thedistal ends of the membrane separating and allowing backflow. Thepassages 102 b may have a width in the range of about 1 mm to about 5 mm(e.g., about 1.5 mm to about 4 mm, about 2 mm to about 3.5 mm, or anyvalue or range of values therein) and the bonding points 102 a may havewidths in the range of about 1 mm to about 3 mm (e.g., about 2 mm, orany value or range of values therein). The width of the bonding points102 a may define the interval between adjacent passages 102 b.

The one-way valve 110 may have a lumen 102 between the dual membranesthat is maintained in a collapsed or nearly collapsed condition, suchthat urine can flow from the collection hole 103 into the proximal endof the dual membrane structure 115, but cannot backflow from theinterior of the lumen collection valve 105 (the interior space of theouter membrane wall 105 a that is external to the dual membranestructure 115) through the distal end of the dual membrane structure 115because the bonding points 102 a do not allow the distal ends of thedual membranes to separate. Thus, the distal end of the one way valve110 may be prevented from opening by the bonding points 102 a. The dualmembrane structure 115 thereby allows liquid to pass through at a lowpressure (e.g., pressure created by gravity flow of a small amount ofliquid, urine, etc.), but prevents the backflow of urine toward thecollection hole 103.

The outer membrane wall 105 a and the one-way internal valve 110together form a collapsible substantially flat structure when urine isnot passing through collection valve 105. FIG. 1D shows the collectionmember 100 which has been rotated 90°. The outer membrane wall 105 a andthe one-way internal valve 110 are shown as a flat structure in whichthere are potential spaces between the interfacing membranes throughwhich urine can flow, when it is present.

Upon urine passing through the one-way valve 110 and into the collectionconduit 105, the urine may be drained through the distal collectionconduit 120. The distal collection conduit 120 may be a semi-rigid,semi-compressible, resilient structure capable of holding its shape. Forexample, it may be made of a various rubber materials, such as siliconerubber, polyurethane rubber, non-vulcanized natural rubber, polystyrenerubbers, polychloroprene, non-latex rubber materials, and other sturdyand (optionally) flexible materials. The distal collection conduit 120may include a connector 125 having a connection mechanism for securelyengaging with a collection receptacle. In the example shown in FIGS.1A-1D, the connector 125 includes ridges at its distal end for engagingwith the interior of a connection tube in the proximal end of acollection receptacle such that the distal collection conduit 120 may besecurely placed in fluid communication with the collection receptacle.The ridges may serve to pressure fit and/or engage with complementaryridges within the connection tube of the collection receptacle. In otherimplementations, the connector 125 may have a different connectionmechanism, such as threading or a quick-connect device. In still otherimplementations, the distal collection conduit 120 may be continuouslyand integrally formed with the collection receptacle.

FIGS. 2A-D collectively show, without limitation, a collection member200 that has some common features with the collection member 100 shownin FIGS. 1A-1D, but includes a different structure than the concavereceiver 136. Referring to FIG. 2A-B, the collection member 200 includesa collection disk 201, a collection valve 205 having a proximal end influid connection with collection disk 201, and collection conduit 220.The collection disk 201 is a circular structure (e.g., a flexible flatdisk) that is made of a flexible and skin-safe material (e.g., siliconerubber, polyurethane rubber, non-vulcanized natural rubber, polystyrenerubbers, polychloroprene, non-latex rubber materials e.g., nitrile, andother appropriate materials) and is operable to be placed at the distalend of the penis (glans penis). The collection disk 201 may include acollection hole 203 and a raised bead 203 a that surrounds thecollection hole 203. FIGS. 2B-2C show the proximal surface of thecollection disk 201 that includes the raised bead 203 a. The collectionhole 203 may be aligned with external urethral orifice with the raisedbead 203 a surrounding the external urethral orifice to prevent leakageand direct urine flow through the collection member 200. The collectionhole 203 shown in FIGS. 2B-2C is elliptical, and it is to be understoodthat the collection hole 203 may alternatively have various shapes,including circular, polygonal, etc. The raised bead 203 a may haveadhesive for attaching and sealing the collection disk 201 to the glanspenis to thereby securely align the collection hole 203 with theexternal urethral orifice.

The collection valve 205 has essentially the same structure as thecollection valve 105 shown in FIGS. 1A-1D, except for the connection atits proximal end to collection disk 201, rather than a concave receiver.The outer membrane wall 205 a (e.g., a sleeve-like polymer structure)may be flexible and water-tight and operable to allow urine to passtherethrough without leakage. The outer membrane wall 205 a may have awater-tight connection at its proximal end with the collection disk 201and at its distal end with distal collection conduit 220. The collectionvalve 205 includes a one-way internal valve 210 that may be nestedwithin the outer membrane wall 205 a, and may have the same constructionas the one-way internal valve 105 described above. The one-way internalvalve 210 may include a flexible dual membrane structure 215 in whichthe lateral edges of the dual membranes are bonded to each other and thedistal ends of the membranes are intermittently bonded together atbonding points 202 a, such that there are intermittent passages 202 bbetween the membranes at or near the distal ends thereof. This dualmembrane structure 215 allows urine to pass downstream from thecollection hole 203 without the distal ends of the membrane separatingand allowing backflow.

The one-way valve 210 may have a lumen 202 between the dual membranesthat is maintained in a collapsed or nearly collapsed condition, suchthat urine flowing from the collection hole 203 into the proximal end ofthe dual membrane structure 215, but cannot backflow from the interiorof the lumen collection valve 205 through the distal end of the dualmembrane structure 215 because the bonding points 202 a do not allow thedistal ends of the dual membranes to separate.

The outer membrane wall 205 a and the one-way internal valve 210together form a collapsible substantially flat structure when urine isnot passing through collection valve 205. FIG. 2D shows the collectionmember 200 which has been rotated 90°. The outer membrane wall 205 a andthe one-way internal valve 210 are shown as a flat structure in whichthere are potential spaces between the interfacing membranes throughwhich urine can flow, when it is present.

The collection member 200 may further include a distal collectionconduit 220, which may have the same construction as the distalcollection conduit 120 described above. The distal collection conduit220 may be a semi-rigid, compressible, resilient structure capable ofholding its shape, and may include a connector 225 having a connectionmechanism for securely engaging with a collection receptacle. In theexample shown in FIGS. 2A-2D, the connector 225 includes ridges at itsdistal end for engaging with the interior of a connection tube in theproximal end of a collection receptacle such that the distal collectionconduit 220 may be securely placed in fluid communication with thecollection receptacle. The ridges may serve to pressure fit and/orengage with complementary ridges within the connection tube of thecollection receptacle. In other implementations, the connector 225 mayhave a different connection mechanism, such as threading. In still otherimplementations, the distal collection conduit 220 may be continuouslyand integrally formed with the collection receptacle.

FIGS. 3A-3B illustrates, without limitation, an adhesive attachmentmember 300 which may be operable to be attached to the outer surface ofthe concave receiver 136 and may aid in attachment of the incontinencecontrol device to the user. The adhesive attachment member 300 may havean adhesive on the upper surface thereof for adhering to both the outersurface of the concave receiver 136 and the skin of the user. Theadhesive may be one that is skin-safe, such as such as a hydrocolloid,acrylic, silicone, latex, or non-latex adhesive formulation. In someembodiments, and without limitation, the adhesive attachment member 300may have a central pad structure that contacts the outer wall of theconcave receiver 136, and adhesive flaps 335 that extend from thecentral pad and beyond the edge of the concave receiver 136, such thatthey may be operable to adhere to the penis, when the concave receiver136 is in contact with the glans penis. The adhesive flaps 335 may bepressed onto the penis on the glans penis and/or above the glans penison the body of the penis.

The adhesive attachment member 300 may also include adhesive straps 350to further aid in attaching the incontinence collection device to thepenis. The adhesive straps 350 may be wrapped around the body of thepenis when the concave receiver 136 is in contact with the glans penis.In some implementations, and without limitation, the straps 350 may bewrapped around the body of the penis after the concave receiver 136 hasbeen adhered to the glans penis and the adhesive flaps 335 have beenadhered to the penis. The combination of the concave receiver 136, theadhesive flaps 335 and the adhesive straps 350 provide for a secureattachment of the incontinence collection device to the penis.

In some embodiments, and without limitation, the adhesive attachmentmember 300 may simply include adhesive straps 350 attached to theconcave receiver 136, as shown in FIG. 5A. The adhesive straps 350 maybe wrapped around the body of the penis when the concave receiver 136 isin contact with the glans penis. In some implementations, and withoutlimitation, the concave receiver 136 may include an adhesive on theinner surface thereof, and the adhesive straps 350 may be wrapped aroundthe body of the penis after the concave receiver 136 has been adhered tothe glans penis. The combination of the concave receiver 136 and thestraps 350 may provide secure attachment of the incontinence collectiondevice to the penis.

FIG. 3C shows an alternative embodiment of the adhesive attachmentmember. Adhesive attachment member 360 may be operable to be engagedwith a collection member like collection member 200 that includes acollection disk 201. The collection member 200 may be positioned withinreceiving hole 370. For example, and without limitation, the distalcollection conduit 220 and the collection valve 205 may be passedthrough the receiving hole 370 such that the collection disk 201 ispositioned over an adhesive area 375, and the collection disk 201 may besecured in position over the receiving hole 370. Subsequently, thecollection disk 201 and the adhesive flaps 365 and adhesive straps 380may be adhered to the penis to secure the incontinence control device tothe user. It is to be understood that the adhesive area 375 may simplybe an area of equivalent size to the collection disk 201 on the adhesiveattachment member 360, and that the entire surface of the adhesiveattachment member 360 shown in FIG. 3C (including the adhesive flaps 365and the straps 380) may have an adhesive thereon.

FIG. 4A shows collection receptacle 400 for receiving urine from thecollection member (e.g., 100) and storing the urine until the user ofthe incontinence collection device drains the urine from the collectionreceptacle 400. The collection receptacle 400 may be a flexible,expandable bladder-like structure that receives and collects urine fromthe collection member (e.g., 100). The collection receptacle 400 mayhave a volume sufficient to hold several hours of average urineexcretion for an adult male. For example, the collection receptacle 400may have a maximum volume in a range of about 8 fluid oz. to about aquart. The collection receptacle 400 may be made of a flexible material(e.g., rubber, polyurethane rubber, non-latex material such as nitrile,etc.) to allow the structure to collapse when empty or nearly empty, andto conform to the body as a person wearing the incontinence collectiondevice moves. The collection receptacle 400 may have a structuralfeatures that allow the receptacle to expand with the flow of urine intothe collection receptacle at relatively low pressures. For example, thecollection receptacle may include billow-like structures at one or morepoints along the wall of the collection receptacle. Such billow-likestructures or pleats may facilitate the collapse of the receptacle intoa flat arrangement. As shown in FIG. 4A, collection receptacle 400 mayhave an expandable pleated side 460 (pleated side 460 is bestillustrated in FIG. 5A).

The collection receptacle 400 may be detachably or integrally connectedto the collection member. In some embodiments, the collection receptaclemay be attached to the collection member indirectly, for example, by alength of tubing. As shown in FIG. 4A, the collection receptacle may beconnected to a collection member (e.g., collection member 100) byengagement of the distal connector 125 of collection member 100 with aconnector 420. Connector 420 may be a tube having engagement structuresthat are complementary to an engagement mechanism of the distalconnector 125. For example, the distal connector 125 may includecircumferential ridges at its distal end for engaging with the interiorof connector 420, which may include internal ribbing for engaging theridges of connector 125 such that the distal conduit 120 may be securelyplaced in fluid communication with the collection receptacle 400. Theridges may serve to pressure fit and engage the ribbing within theconnector 420. In other implementations, the connector 125 and theconnector 420 may share a different connection mechanism, such as aquick connect device or complementary threading. In still otherimplementations, the distal collection conduit 120 may be continuouslyand integrally formed with the collection receptacle 400. The connectionbetween the collection member 100 and the collection receptacle 400allows urine to pass from the collection member 100 into collectionreceptacle 400.

The collection receptacle 400 may include a one-way valve of variousdesigns. In some embodiments, the collection receptacle 400 may includea one-way valve 410 that may be nested within the outer walls of thecollection receptacle. The one-way valve 410 may be similar in structureto the one-way valve of the collection member (e.g., one-way valve 110).The one-way internal valve 410 may have a flexible dual membranestructure 415 in which the lateral edges of the dual membranes arebonded to each other and the distal ends of the membranes areintermittently bonded together at bonding points 402 a, such that thereare intermittent passages 402 b between the membranes at or near thedistal ends thereof. The one-way valve 410 may have a lumen 402 betweenthe dual membranes that is maintained in a collapsed or nearly collapsedcondition. This dual membrane structure 415 allows urine to passdownstream from the connector 420 through the one-way valve 410 withoutthe distal ends of the membrane separating and allowing backflow. Thepassages 402 b may have a width in the range of about 1 mm to about 20mm (e.g., about 5 mm to about 15 mm, about 8 mm to about 12 mm, or anyvalue or range of values therein) and the bonding points 402 a betweenthe membranes may have widths in the range of about 1 mm to about 20 mm(e.g., about 3 mm to about 18 mm, about 5 mm to about 15 mm, or anyvalue or range of values therein). The width of the bonding points 402 amay define the interval between adjacent passages. The one-way valve 410of the collection receptacle 400 allows urine to pass at low pressure(e.g., seep through the plurality of passages 402 b) and flow into theouter lumen 461 of the collection receptacle 400 for storage. In someimplementations, the dual membrane one-way valve 410 may be connectedalong its lateral edges to the interior of the collection receptacle 400in order to aid in keeping the dual membrane structure 415 in aflattened arrangement with the two membranes of the dual membranestructure 415 interfacing with one another in close proximity. Theconnection of the dual membranes to the interior of the collectionreceptacle 400 may aid in preventing backflow of urine through theone-way valve 410 to the collection member.

The collection receptacle 400 may include a drainage valve 465 at itsdistal end that may be manually operated by the user. To aid in the flowof urine when the drainage valve 465 is in an open condition, thecollection receptacle 400 may also include an air relief valve 450positioned in the outer wall of the collection receptacle 400. The airrelief valve 450 may aid in draining the urine from the collectionreceptacle 450 by allowing air to flow into the collection receptacle400 as the urine is drained through the drainage 465 valve and therebypreventing the creation of a vacuum within the collection receptacle400. As shown in FIG. 4A, the collection receptacle 400 includes an airrelief valve 450 through which air may be drawn as urine is drained fromthe collection receptacle through the drainage valve. It is to beappreciated that the air relief 450 may include a liquid-proof valve(not shown) that prevents urine from being released from air reliefvalve 450.

FIGS. 4A-4E show exemplary embodiments of a drainage valve 465 for theincontinence collection device of the present invention. For example,FIG. 4A shows a drainage valve 465 that may include a drainage conduit466 to collect urine at the distal end of collection chamber 400, avalve mechanism 470, and a valve actuator 475 for opening the valvemechanism 470. The drainage conduit 466 may be a rigid or semi-rigidpolymer structure, such as a resilient flexible rubber structure thatcan maintain its shape, but may allow limited bending and manipulation(e.g., rubber, vulcanized rubber, etc.). Urine may flow by gravity tothe distal end of the collection receptacle 400 and through the valvemechanism 470, when the user engages the valve actuator 475. In theexample shown in FIG. 4A, the valve mechanism is a biased cross valve,that is biased to a closed position, and the user must push in the valveactuator 475 (a push button) in order to open the valve. Cross valve 470has an opening (not shown) that aligns with the lumen of the drainageconduit when cross valve is pushed in, allowing urine to drain from thecollection receptacle 400. The collection receptacles of the presentinvention may alternatively include other kinds of valve structures.Some alternative valve structures are discussed below.

FIGS. 4B-4E illustrate other embodiments of the drainage valve for theincontinence collection device of the present invention. It is to beunderstood that the following exemplary drainage valves would be asubstitute for the drainage valve 465 shown in FIG. 4A, and would beengaged with the drainage conduit 466 or integrally formed with thedistal end of the collection receptacle 400. FIG. 4B-4D shows anembodiment of the drainage valve having a pinch valve structure. Thepinch valve 480 comprises a compressible bulb 486, an actuator 482 thatincludes at least two (e.g., two, three, four, six, etc.) resilient arms482 a and 482 b that project inferiorly within the compressible bulb486. The at least two resilient arms 482 a and 482 b each have elbows482 c which engage with the interior of the compressible bulb 486 atpoints 486 a and 486 b. The at least two resilient arms 482 a and 482 bmay be mechanically attached to the compressible bulb 486 such that theactuator 482 kept in position within the compressible bulb 486. Theactuator 482 also has a central piston member 482 d including at leastone bar connected to a plug 483. The plug 483 may have a shape that isoperable to engage and obstruct a tapered distal hole 487 at the distalend of the compressible bulb 486, to thereby prevent any fluid fromflowing from the distal hole 487. The plug 483 may include a distal peg483 a at its distal end that has a complementary shape to a distal hole487 of the compressible bulb 486.

The function of the actuator 482 is to prevent urine from being releasedfrom the collection receptacle 400 until the user pinches the pinchvalve 480. Upon pinching at or near points 486 a and 486 b ofcompressible bulb 486 (e.g., according to arrows A and B), the elbows482 a and 482 b are squeezed and elongated within the pinch valve 480.As the elbows 482 a and 482 b are squeezed and elongated, the anglebetween the upper and lower portions of each arm increases and theangles between the arms and the central piston member 482 d decrease,and the central piston member 482 d is retracted from the distal hole487 of the compressible bulb 486. FIG. 4C shows the compressed conditionof the compressible bulb 486 and actuator 482 when the user pinches thecompressible bulb 486. In the compressed condition, the plug 483 isremoved from the distal hole 487, thereby allowing urine to flow fromthe collection receptacle 400.

As previously mentioned, the actuator 482 is a resilient structure thatresiles to its original shape once the user releases the compressiblebulb 486, thereby returning the plug 483 and peg 483 a into originalposition to obstruct the distal hole 487 of the compressible bulb 486.The actuator 482 may maintain its position within the compressible bulb486 and thereby allow the plug 483 to return to its original position bythe mechanical connection between the elbows 482 c and points 486 a and486 b within the compressible bulb.

The pinch valve 480 as shown in FIGS. 4B-4C is detachable from thecollection receptacle 400, having ridges that may serve to pressure fitand/or engage with complementary ridges within the distal conduit of thecollection receptacle 400. In other implementations, the pinch valve 480may have a different connection mechanism, such as threading. In stillother implementations, the pinch valve 480 may be continuously andintegrally formed with the collection receptacle 400. As shown in FIG.4D shows a pinch valve 480 wherein the pinch valve 480 is integrallyformed with the distal conduit of the collection receptacle 400.

Variations in the pinch valve 480 structure shown in FIGS. 4B-4D arewithin the scope of the present invention. In some embodiments of thepresent invention, e.g., the actuator 482 may include more than 2resilient arms (e.g., 3, 4, 5, 6, or more) that may radiate from thecentral piston member 482 d in a symmetrical pattern. With additionalarms, the user may be able to squeeze the compressible bulb 486 betweenany two diametric or about diametric points on the circumference of thecompressible bulb 486 and compress the actuator 482. In someembodiments, and without limitation, the resilient arms (e.g., 482 a and482 b) may have various designs, including broader arms to increase thesurface area of the interface between the resilient arms and theinterior of the compressible bulb 486, resilient arms that terminate atthe contact between the arms and the bulb (the “elbows”), and variousother designs. Additionally, in some embodiments, the plug 483 may haveother shapes such as a conical shape that tapers at the distal end, anellipsoid shape, etc. In some embodiments, the plug 483 may also includea hydrophobic outer material or coating (e.g., hydrophobic polyol,polyether polyol, amine-initiated polyol, carbodiimide-modified MDI,polymeric MDI, etc.) to aid in preventing urine from passing through thedistal hole 487 of the compressible bulb 486 until it is compressed.

FIG. 4E shows a further exemplary embodiment of the drainage valve 490having a biased door 494 for covering the distal drainage hole of thecollection receptacle. The drainage valve 490 includes a connector 491for engaging and securing to the distal drainage conduit of thecollection receptacle 400, a length of tube 495, and a sealing member493. The sealing member 493 includes a spring-biased joint 492 that isfixedly attached to the tube 495, and a door 494 that is fixedlyattached to the spring-biased joint 492. The door 494 may include alever portion 494 a that the user can press to reduce the angle betweenthe lever portion 494 a and the tube 495, and thereby open the drainagevalve 490. Spring-biased joint 492 prevents the door 494 from openingwithout the user pressing the lever portion 494 a. The perimeter of thedoor 494 may have a flexible, compressible O-ring or lip (e.g., madefrom rubber, vulcanized rubber, polyurethane, etc.) 494 a to preventurine from leaking through the drainage valve 490. In some embodiments,the door 494 may also include a hydrophobic outer layer or coating(e.g., hydrophobic polyol, polyether polyol, amine-initiated polyol,carbodiimide-modified MDI, polymeric MDI, etc.) on the area of the door494 that engages with the distal rim of the tubing 495 to aid inpreventing urine from leaking from the drainage valve 490. The drainagevalve 490 may be attached to the distal drainage conduit 466 of thecollection receptacle 400 by ridges that may serve to pressure fitand/or engage with complementary ridges within the distal conduit of thecollection receptacle 400. In other implementations, the drainage valve490 may have a different connection mechanism, such as threading. Instill other implementations, the drainage valve 490 may be continuouslyand integrally formed with the collection receptacle 400.

FIGS. 5A-5D illustrate exemplary embodiments of the incontinencecollection device of the present invention in full assembly, including acollection receptacle 400 in fluid connection with the distal collectionconduit 120 of the collection member 100. FIG. 5A shows an exemplaryembodiment in which collection member 100 is attached to collectionreceptacle 400 via the coupling of connector 125 to connector 420. Inthis embodiment, the incontinence collection device is attached to thepenis by the concave receiver 136 and the adhesive straps 350. Theconcave receiver 136 may have an adhesive on the interior thereof and,in combination with the adhesive straps 350, may have sufficientadhesive to provide an adequately strong and reliable connection withthe glans penis. In other implementations, the concave receiver 136 mayonly include adhesive on the raised bead 103 a, and the adhesive straps350 may provide most of the strength of attachment between theincontinence collection device and the penis. Additionally, theincontinence collection device shown in FIG. 5A may be further supportedby an undergarment into which the incontinence collection device may beinserted during use. Such undergarments are discussed herein below.

FIG. 5B shows an embodiment in which the adhesive attachment structure(e.g., adhesive straps 350) is not included because the concave receiver136 may have sufficient adhesive in the interior thereof to provide anadequately strong and reliable connection with the glans penis.Additionally, the incontinence collection device shown in FIG. 5B may befurther supported by an undergarment into which the incontinencecollection device may be inserted during use. Such undergarments arediscussed herein below.

FIG. 5C shows a further exemplary embodiment of the incontinencecollection device that includes a collection member 100, a collectionreceptacle 400, and an adhesive attachment member. As in the embodimentshown in FIG. 5B, the collection member 100 is attached to collectionreceptacle 400 via the coupling of distal connector 125 to connector420. The embodiment of FIG. 5C further includes an adhesive attachmentmember 300 attached to the outer wall of the concave receiver 136. Inthis embodiment, the adhesive flaps 335 and adhesive straps 350 mayassist in attaching and securing the incontinence collection device tothe user. In some implementations, and without limitation, the concavereceiver 136 may or may not have an adhesive material therein, and theincontinence collection device may be adhered to the penis by theadhesive flaps 335 and an adhesive straps 350 alone. In furtherembodiments, the adhesive flaps 335 or the adhesive straps 350 may beselective omitted from the incontinence collection device.

FIG. 5D is a further exemplary embodiment of the incontinence collectiondevice of the present invention in which the collection member 200 isattached to the collection receptacle 400 and the adhesive attachmentmember 360. The collection member 200 is attached to collectionreceptacle 400 via the coupling of connector 225 to connector 420. Theadhesive attachment member 360 is engaged to and secured to thecollection disk 201 of the collection member 200. To attach thecollection member 200 to the adhesive attachment member 360 thecollection disk 201 may be passed on its side through hole 370(including the lateral slots in hole 370) in the adhesive attachmentmember 360. Once the collection disk 201 is passed through hole 370, theposterior side of the collection disk 201 may be secured to the adhesivearea 375, thereby providing a stable reliable connection between theadhesive attachment member 360 and the collection member 200. Theadhesive flaps 365 and adhesive straps 380 may then be used to attachthe incontinence control device to the penis.

FIGS. 6A-6C show an exemplary process for securing the incontinencecollection device of the present invention to the penis. It is to beappreciated that the process shown in FIGS. 6A-6C is exemplary, and thatother embodiments of the incontinence collection device (e.g., theembodiment of FIG. 5A) may be attached to the penis 500 using fewerattachment structures than shown in FIGS. 6A-6C. As shown in FIG. 6A,the glans penis 510 may be aligned with the raised bead 103 a of theconcave receiving member 136, such that the external urethral orifice isaligned with collection hole 103. FIG. 6A shows a dashed line on theglans penis 510 where the raised bead 403 a may be positioned. Theconcave receiving member 136 may include an adhesive such that the usermay secure the concave receiving member 136 to the glans penis 510 oncethe collection hole 103 is aligned with the external urethral orifice.

As shown in FIG. 6B, adhesive flaps 335 may subsequently be attached tothe penis 500 proximally relative to the concave receiving member 136(e.g., on the glans penis 510 and/or the body 520 of the penis) toprovide further strength to the connection between the incontinencecontrol device. However, it is to be understood that certain structuresmay be omitted in some embodiments. For example, the adhesive flaps 335may be omitted and the incontinence collection device may be attached bythe concave receiver 136 and the adhesive straps 350 alone, as shown inthe embodiment shown in FIG. 5A.

As shown in FIG. 6C, the adhesive straps 350 may subsequently be wrappedaround and attached to the penis 500. The adhesive straps 350 may inpart overlap with the concave receiver 136 and/or the adhesive flaps335, and they may also attach to the penis 500 proximally relative tothe concave receiving member 136 and the adhesive flaps 335 (e.g., onthe glans penis 510 and/or the body 520 of the penis) to provide furtherstrength to the connection between the incontinence collection device.It is to be appreciated that not all attachment structures must bepresent and not all attachment structures must have adhesive (e.g., insome embodiments, the concave receiving device may have adhesive solelyon the raised bead 103 a). It is to be appreciated that FIGS. 6A-6C arenot meant to limit the invention to having all of the describedattachment members. Rather, the figures have been provided and describedto illustrate a preferred embodiment of the present invention.

FIGS. 7A-7E show a devices and techniques for securing the incontinencecollection device to the user, such that the user can comfortably wearthe incontinence collection device during movement and activity. Thepresent invention may include an undergarment that includes a detachablesleeve into which the collection receptacle of the incontinencecollection device may be inserted. The detachable sleeve may include anattachment mechanism for engaging and supporting the weight of theincontinence collection device, preventing detachment of theincontinence collection device from the user, and reduce discomfort thatmay result from walking or other motion.

As shown in FIG. 7A-7C, the undergarment 700 may have a boxer-short orboxer-brief-like design having legs 701, a waistband 703, and a 2″-3″slit 708 through which the penis may protrude with the incontinencecollection device attached thereto. A sleeve 705 may be detachablyconnected to the waist band 703 or other superior portion of theundergarment 700 by an attachment mechanism 702, such as a fabrichook-and-loop fastening mechanism (e.g., Velcro) having a firstfastening panel on the waistband 703 made up of semi-rigid hooks and asecond fastening panel on the superior portion of the detachable sleeve705 made up of soft fabric loops. When the two sides of thehook-and-loop fastening mechanism are brought together the hooks engagewith the loops and hold the two sides together. The detachable sleeve705 may have an open proximal end 705 a through which the collectionreceptacle may be passed, and an attachment mechanism 711 for attachingthe collection receptacle to the interior of the detachable sleeve 705.The attachment mechanism 711 may be a hook and loop mechanism, wherethere is a first attachment panel 711 a on the interior of thedetachable sleeve 705 made up of semi-rigid hooks and a secondattachment panel 711 b on the collection receptacle made up of softfabric loops. The second attachment panel 711 b may be positioned on theproximal end of the collection receptacle 400, allowing the collectionreceptacle 400 to hang from the hook/loop attachment on its proximalend.

The distal end of the detachable sleeve 705 may have an opening 710through which the drainage valve of the incontinence control device maybe accessed. The distal opening 710 may allow the user to drain thecollection receptacle 400 conveniently without having to remove anyportion of the undergarment 700 or dismantle the incontinence controldevice.

FIGS. 7D-7E show an alternative undergarment for securing theincontinence control device to the user. The undergarment 800 may have aboxer-short or boxer-brief-like design having legs 801, undercarriage802, and a waistband 803. The undergarment 800 also may include a pouch810 for receiving and supporting the collection receptacle 400 of theincontinence control device, which may be located on the interior of theundergarment 800.

The pouch 810 may include a securing mechanism 811 for attaching andsecuring the collection receptacle 400 within the pouch 810. Forexample, the securing mechanism 811 may be a fabric hook-and-loopfastening mechanism having a first fastening panel within the pouch 810and a second fastening panel on the proximal portion of the collectionreceptacle 400 (as shown in FIG. 7B). In other embodiments, thecollection receptacle 400 may be attached and secured to the pouch 810by other fastening mechanisms such as snap buttons, a flap that closesover the pouch and seals by button(s) or other mechanisms, or otherfastening members. As shown in FIGS. 7D-7E, the pouch 810 may include afastening panel 811 a and the collection receptacle 400 may include acomplementary fastening panel 811 b. When the collection receptacle 400is inserted into the pouch 810, the fastening panel 811 b may be alignedand connected with the fastening panel 811 a within the pouch 810, suchthat the collection receptacle 400 is securely hung in the pouch 810 andwill not dislodge from the pouch 810 when the user walks or engages inother movements.

FIG. 7E shows the undergarment 800 with the collection receptacle 400positioned inside of the pouch 810. The complementary fastening panels811 a and 811 b are aligned with and secured to one another to maintainthe position of the collection receptacle 400 within the pouch 810. Itis to be understood that the undergarment 800 may include differentmechanisms for supporting the collection receptacle, e.g., theundergarment may include one or more straps that pass through one ormore loops on the collection receptacle to fasten the collectionreceptacle in position. Such variations are within the scope of thepresent invention, which is not limited to the examples provided in thedrawings.

CONCLUSION

The present invention provides a novel external male incontinencecollection device, which allows the user to attach the device in anoptimal position. Furthermore, the present invention features aninternal one-way valve system within the collection conduit thatprevents backflow of urine from a urine receptacle. The one-way valvesystem prevents the backflow of and the dissolution of the adhesiveattaching the device to the user. Furthermore, novel exit valves havebeen described in the present application that allow for the easyrelease and drainage of urine from the incontinence collection device.

It is to be understood that variations, permutations, and modificationsof the present invention may be made without departing from the scopethereof. One or more features of an exemplary embodiment as describedabove may be practiced in conjunction with other exemplary embodimentsas described above. It is also to be understood that the presentinvention is not to be limited by the specific embodiments disclosedherein, but only in accordance with the appended claims when read inlight of the foregoing specification.

1. An incontinence collection device, comprising: a. an attachmentmember having an exit hole for allowing the passage of urine, whereinsaid attachment member is operable to attach to a distal end of a penis;b. a collection member connected to said attachment member, thecollection member comprising: i. a collection conduit having a proximalend in fluid communication with said attachment member, ii. a one-wayinternal valve in fluid communication with said collection conduit, saidone-way internal valve comprising a flexible dual membrane structurewherein distal ends of said dual membrane structure includesintermittent passages that allow urine to pass downstream whilepreventing backflow of urine; and iii. a distal conduit; and c. acollection receptacle in fluid communication with said distal conduit ofsaid collection member.
 2. The device of claim 1, further comprising adrainage conduit in fluid communication with said collection receptacleoperable to drain fluid from said collection receptacle.
 3. The deviceof claim 1, wherein said attachment member includes a concave receiveroperable to engage with said end of said penis.
 4. The device of claim2, wherein said concave receiver is conformable to the end of said penisand said concave receiver has an adhesive on an interior thereof foradhering said concave receiver to said penis.
 5. The device of claim 2,wherein said concave receiver has a raised bead on the interior thereofthat surrounds said exit hole.
 6. (canceled)
 7. The device of claim 1,wherein said attachment member further comprises at least one adhesivestrap extending from said concave receiver for attaching to said penis.8. (canceled)
 9. The device of claim 1, wherein said collectionreceptacle includes a second one-way valve for preventing backflow fromsaid collection receptacle.
 10. (canceled)
 11. The device of claim 1,wherein said collection receptacle includes an exit conduit and adrainage valve to allow a wearer to control drainage of fluid from saidcollection receptacle.
 12. The device of claim 11, wherein said drainagevalve is a pinch valve comprising: a. a compressible bulb having adrainage hole in a distal end thereof; and b. a resilient, flexiblevalve mechanism comprising: i. an actuator having at least two resilientarms having a flexible joint, said arms being in mechanical connectionwith an interior of said compressible bulb; ii. a central memberincluding: a. a piston member having a proximal end that is mechanicallyconnected to proximal ends of said resilient arms, and a distal end, b.a plug attached to said distal end of said bar, wherein said plug isoperable to seal said drainage hole.
 13. (canceled)
 14. (canceled) 15.(canceled)
 16. (canceled)
 17. (canceled)
 18. (canceled)
 19. (canceled)20. (canceled)
 21. (canceled)
 22. (canceled)
 23. (canceled) 24.(canceled)
 25. (canceled)
 26. (canceled)
 27. (canceled)
 28. (canceled)29. (canceled)
 30. (canceled)
 31. (canceled)
 32. (canceled) 33.(canceled)
 34. (canceled)
 35. (canceled)
 36. (canceled)
 37. (canceled)38. (canceled)
 39. (canceled)
 40. (canceled)
 41. (canceled)
 42. Thedevice of claim 1, wherein said attachment member includes an adhesiveon a surface thereof.
 43. The device of claim 1, further comprising anair relief valve in fluid communication with said collection receptacle.44. The device of claim 9, wherein: a. said collection receptaclecomprises a flexible material, allowing said collection receptacle tocollapse when empty or nearly empty; and b. said second one-way valvecomprises a collapsible dual membrane structure wherein said dualmembranes are positioned substantially parallel to said flexiblematerial of said collection receptacle when empty or nearly empty. 45.The device of claim 44, wherein said dual membranes of said collapsibledual membrane structure comprise distal ends, said distal ends beingintermittently bonded together.
 46. The device of claim 45, wherein saidcollapsible dual membrane structure comprises intermittent passagesbetween said dual membranes, allowing urine to pass downstream andpreventing backflow of urine.
 47. The device of claim 46, wherein saidintermittent passages have a width in the range of about 1 mm to about20 mm.
 48. The device of claim 44, wherein said collapsible dualmembrane structure comprises a lateral edge, said lateral edge beingattached to an interior surface of said collection receptacle to aid inpreventing backflow of urine.
 49. An incontinence collection device,comprising: a. an attachment member comprising a concave receiver havinga collection hole, said concave receiver being operable to connect saidincontinence collection device with the end of a penis b. a collectionmember in fluid communication with said attachment member, saidcollection member comprising a one-way valve in fluid communication withsaid collection hole that is operable to prevent backflow of urine; andc. a collection receptacle in fluid communication with said collectionmember.
 50. The device of claim 49, further comprising a drainageconduit in fluid communication with said collection receptacle operableto drain fluid from said collection receptacle.
 51. The device of claim49, wherein said collection receptacle includes a second one-way valvefor preventing backflow from said collection receptacle.
 52. The deviceof claim 49, wherein said concave receiver includes a raised beadsurrounding said collection hole on the interior thereof.
 53. The deviceof claim 49, wherein said concave receiver is conformable to the end ofsaid penis and said concave receiver has an adhesive on an interiorthereof for adhering said concave receiver to said penis.
 54. The deviceof claim 49, wherein the attachment member further comprises at leastone adhesive flap extending from said concave receiver for attaching toa shaft of said penis.
 55. The device of claim 49, wherein said firstone-way valve includes flexible dual membranes that are connectedtogether at their edges and have intermittent passages between the dualmembranes at distal ends thereof.
 56. The device of claim 50, furthercomprising a drainage valve in fluid communication with said drainageconduit, wherein said drainage valve is a pinch valve comprising: a. acompressible bulb having a drainage hole in a distal end thereof; and b.a resilient, flexible valve mechanism comprising: i. an actuator havingat least two resilient arms having a flexible joint, said arms being inmechanical connection with an interior of said compressible bulb; ii. acentral member including:
 1. a piston member having a proximal end thatis mechanically connected to proximal ends of said resilient arms, and adistal end,
 2. a plug attached to said distal end of said piston member,wherein said plug is operable to seal said drainage hole.
 57. The deviceof claim 49, further comprising a securing garment operable to attach toa portion of the user's body and having a sleeve for holding saidcollection receptacle, wherein said securing garment has an attachmentmechanism for securing said collection receptacle in position in saidsleeve.
 58. An incontinence collection device, comprising: a. anattachment member having an exit hole for allowing the passage of urine,wherein said attachment member is operable to attach to a distal end ofa penis; b. a collection member connected to said attachment member, thecollection member comprising a one-way internal valve in fluidcommunication with a collection conduit, said one-way internal valvecomprising a flexible dual membrane structure having intermittentpassages between the membranes that allow urine to pass downstream whilepreventing backflow of urine; and c. a collection receptacle in fluidcommunication with said collection member.
 59. The device of claim 58,further comprising a drainage conduit in fluid communication with saidcollection receptacle operable to drain fluid from said collectionreceptacle.
 60. The device of claim 58, wherein said attachment memberincludes a concave receiver operable to engage with said end of saidpenis, wherein said concave receiver is conformable to the end of saidpenis and said concave receiver has an adhesive on an interior thereoffor adhering said concave receiver to said penis.
 61. The device ofclaim 60, wherein said concave receiver has a raised bead on theinterior thereof that surrounds said exit hole.
 62. The device of claim60, wherein said attachment member further comprises at least oneadhesive strap extending from said concave receiver for attaching tosaid penis.
 63. The device of claim 58, wherein said collectionreceptacle includes a second one-way valve for preventing backflow fromsaid collection receptacle.
 64. The device of claim 59, wherein saidcollection receptacle includes said drainage conduit and a drainagevalve to allow a wearer to control drainage of fluid from saidcollection receptacle.
 65. The device of claim 64, wherein said drainagevalve is a pinch valve comprising: c. a compressible bulb having adrainage hole in a distal end thereof; and d. a resilient, flexiblevalve mechanism comprising: iii. an actuator having at least tworesilient arms having a flexible joint, said arms being in mechanicalconnection with an interior of said compressible bulb; iv. a centralmember including: a. a piston member having a proximal end that ismechanically connected to proximal ends of said resilient arms, and adistal end, b. a plug attached to said distal end of said piston member,wherein said plug is operable to seal said drainage hole.